Back to resultsA Randomised Pilot Study to Assess Differences in Stimulation Induced Paresthesia Between 2 Spinal Cord Stimulation Systems (CHARACTER SCS)
Primary Purpose
Chronic Pain
Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Treatment with the Axium SCS system
Treatment with the Medtronic SCS System
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- Subject is appropriate for SCS implantation according to standard criteria
- Subject is >18 to <75 years old
- Subject is able and willing to comply with the follow-up schedule and protocol
- Subject has chronic (> 6 months) uni/bi-lateral neuropathic pain in the lower limb(s) (below the knee) with predominant foot pain
- Minimum baseline pain rating of 50 mm on the VAS in the primary region of pain
- Subject is able to provide written informed consent
Exclusion Criteria:
- Subject has no other exclusion criteria for SCS implantation according to standard criteria
- Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
- Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
- Subject has participated in another clinical study within 30 days
- Subject has been previously treated with and failed to respond to an implantable neuromodulation therapy
Sites / Locations
- Academisch Medisch Centrum
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Axium SCS System
Medtronic SCS System
Arm Description
Implantation with the Axium Neurostimulator
Implantation with the Medtronic Prime Advanced Dorsal Column Stimulation System
Outcomes
Primary Outcome Measures
Specificity of Stimulation Induced Paresthesia
A comparative analysis will be made between groups to determine the percentage of a patients painful and non-painful anatomy that is covered by stimulation induced paresthesia
Stability of Stimulation Induced Paresthesia
A comparative analysis will be made between groups to determine any changes in the intensity of stimulation induced paresthesia in response to changes in body position
Patient Interactions with System
A comparative analysis will be made between groups to determine the number of device interactions patients need to have on average, daily
Secondary Outcome Measures
Full Information
NCT ID
NCT02250469
First Posted
September 9, 2014
Last Updated
November 8, 2022
Sponsor
Abbott Medical Devices
1. Study Identification
Unique Protocol Identification Number
NCT02250469
Brief Title
A Randomised Pilot Study to Assess Differences in Stimulation Induced Paresthesia Between 2 Spinal Cord Stimulation Systems
Acronym
CHARACTER SCS
Official Title
A Randomised Pilot Study to Assess differenCes in tHe Subjects' Experience of stimulAtion-Induced paRaesthesiA Between Two Different Spinal Cord sTimulation dEvices: the Axium® DoRsal Root Ganglion Stimulation System Versus the Prime Advanced Dorsal Column Stimulation System
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
12-SMI-2014 is a post-market, randomised, pilot study to identify and rate differences in patient experiences with two different types of Spinal Cord Stimulator devices which are routinely used to treat chronic pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Axium SCS System
Arm Type
Active Comparator
Arm Description
Implantation with the Axium Neurostimulator
Arm Title
Medtronic SCS System
Arm Type
Active Comparator
Arm Description
Implantation with the Medtronic Prime Advanced Dorsal Column Stimulation System
Intervention Type
Device
Intervention Name(s)
Treatment with the Axium SCS system
Intervention Type
Device
Intervention Name(s)
Treatment with the Medtronic SCS System
Primary Outcome Measure Information:
Title
Specificity of Stimulation Induced Paresthesia
Description
A comparative analysis will be made between groups to determine the percentage of a patients painful and non-painful anatomy that is covered by stimulation induced paresthesia
Time Frame
3 Months post implantation
Title
Stability of Stimulation Induced Paresthesia
Description
A comparative analysis will be made between groups to determine any changes in the intensity of stimulation induced paresthesia in response to changes in body position
Time Frame
3 Months post implantation
Title
Patient Interactions with System
Description
A comparative analysis will be made between groups to determine the number of device interactions patients need to have on average, daily
Time Frame
3 Months post implantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is appropriate for SCS implantation according to standard criteria
Subject is >18 to <75 years old
Subject is able and willing to comply with the follow-up schedule and protocol
Subject has chronic (> 6 months) uni/bi-lateral neuropathic pain in the lower limb(s) (below the knee) with predominant foot pain
Minimum baseline pain rating of 50 mm on the VAS in the primary region of pain
Subject is able to provide written informed consent
Exclusion Criteria:
Subject has no other exclusion criteria for SCS implantation according to standard criteria
Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
Subject has participated in another clinical study within 30 days
Subject has been previously treated with and failed to respond to an implantable neuromodulation therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M W Hollmann, Prof
Organizational Affiliation
AIDS Malignancy Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academisch Medisch Centrum
City
Amsterdam
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
A Randomised Pilot Study to Assess Differences in Stimulation Induced Paresthesia Between 2 Spinal Cord Stimulation Systems
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